Evaluation of the Characteristics of Alli® Purchasers in the European Union Following the Revision to the Alli® Pack Information.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- To estimate the proportion of Alli® purchasers aged <18 years.
研究概览
简要总结
Following results from the first survey that forms part of the EU RMP for Alli® (RMP survey 1; WEUSRTP3350), several amendments to the information included on the pack carton for Alli® (orlistat 60 mg) were recommended. The main finding from RMP survey 1 was that a large proportion of Alli® users had a body mass index (BMI) less than (<)28 kg/m2 . (Note: the European indication for Alli® is adults 18 years and older with a BMI<28 kg/m2.) The proportion of respondents overall who reported possible contraindications to Alli® use was relatively low. The following changes to the pack labeling were agreed and have been implemented: : (1) a statement, highlighting the product is only for those with a BMI of 28 or above was added to the front of the pack; (2) wording of the BMI statement on the back of the pack was strengthened; (3) contraindications were highlighted in bold text; (4) the statement that Alli® is not for use by those under 18 years of age was modified for clarity. In addition, a pharmacy reminder card was made available to retail pharmacists to improve awareness of the prescribing information for Alli®. The survey will assess whether compliance with the authorized indication and contraindications among purchasers of Alli® has been improved after one year of marketing the revised pack labeling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any individual who purchases Alli from a pharmacy for their own personal use and provides consent.
排除标准
- •No exclusion criteria.
研究组 & 干预措施
Alli® 60 mg
Participants purchasing Alli®
干预措施: Alli® 60 mg (Drug)
结局指标
主要结局
To estimate the proportion of Alli® purchasers aged <18 years.
时间窗: More than one year following introduction of updated labeling.
The survey will collect the demographic details including age.
To estimate the proportion of Alli® purchasers with a BMI <28 kg/m2.
时间窗: More than one year following introduction of updated labeling.
BMI will be calculated from self-reported weight and height measures.
次要结局
- For Alli® purchasers who have previously used OTC orlistat, descriptive data on the daily dose taken (number of capsules [or tablets]) will be collected.(More than one year following introduction of updated labeling.)
- To estimate the proportion of Alli® purchasers with contraindications to use (ciclosporin use, chronic malabsorption syndrome, cholestasis, pregnancy, breastfeeding, warfarin use).(More than one year following introduction of updated labeling.)
- To characterise the demographic characteristics of Alli® purchasers in the EU and their patterns of previous use of over-the-counter (OTC) orlistat (defined as Alli® capsules or a generic equivalent, or alli chewable tablets).(More than one year following introduction of updated labeling.)
- To estimate the proportions of Alli® purchasers who have previously used OTC orlistat and who have a history of kidney disease or who are taking levothyroxine.(More than one year following introduction of updated labeling.)
- To provide a descriptive comparison between the results of this survey and the previous surveys.(More than one year following introduction of updated labeling.)